An interventional study of Actinica, 0.8 mg/cm2, 1 application and Actinica, 0.8 mg/cm2, 2 applications in Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin, sponsored by Galderma R&D. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
Study centers A total of 20 subjects will be enrolled in 1 site in France.
Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.
There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.
Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.
The clinical investigation will be conducted in 2 parts.
Part 1 - SPF determination:
To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).
Part 2 - Sun exposure:
To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.
133 studies on the registry are indexed under Erythema; 11 are open to participants now.
This study's enrollment of 20 is below the median of 59 across 110 interventional studies indexed under Erythema.
Browse Erythema studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Actinica, 0.8 mg/cm2, 1application over one day of sun exposure
Device: Actinica, 0.8 mg/cm2, 1 application
Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure
Device: Actinica, 0.8 mg/cm2, 2 applications
Actinica, 2 mg/cm2, 1 application over one day of sun exposure
Device: Actinica, 2 mg/cm2, 1 application
Actinica, 2 mg/cm2, 1 application over one day of sun exposure
Device: Actinica, 2 mg/cm2, 2 applications
erythema score
Time frame: Part 2 -Day 1
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Galderma R&D